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U.S. Department of Health and Human Services

Class 2 Device Recall Heartstart

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 Class 2 Recall
Heartstart
see related information
Date Posted March 23, 2010
Recall Status1 Terminated on May 23, 2013
Recall Number Z-1196-2010
Recall Event ID 53816
Premarket Notification
510(K) Number
K040904 
Product Classification Over-The-Counter Automated External Defibrillator - Product Code NSA
Product Heartstart HS1 Defibrillator Model M5068A
Code Information DOMESTIC UNIT SERIAL NUMBERS - A09J-02644, A09J-02180, A09J-02643, A09J-02499, A09J-02169, A09J-02175, A09J-02554, A09J-02645, A09J-01891, A09J-02382, A09J-01903, A09J-02361, A09J-02380, A09J-02033, A09J-02409, A09J-01904, A09J-02351, A09J-02384, A09J-02675, A09J-02625, A09J-02628, A09J-01901, A09J-02360, A09J-02485, A09J-02631, A09J-02642, A09J-02641, A09J-02383, A09J-02647, A09J-02693, A09J-02269, and A09J-02552., A09J-02493, and A09J-01974.
Recalling Firm/
Manufacturer
Philips Medical Systems
2301 5th Ave Ste 200
Seattle, Washington 98121
Manufacturer Reason
for Recall
Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm notified their US distributors of the recall and instructed them to contact customers and provide information how to return the product to Philips for a free replacement. Firm contacted distributors via phone and email on 11/2/09 and by letter on 11/9/09. A web site providing information related to the recall was activated on 11/3/09.
Quantity in Commerce 34 units distributed domestically
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NSA and Original Applicant = PHILIPS MEDICAL SYSTEMS
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